MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. PREMILENE 3/0 (2) 90CM 2XHRC26 CV; POLYPROPYLENE SUTURE

Model Number C2090812

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Customer reported that the threads recently tear off easily.

Manufacturer Narrative

Us reporting agent notification received: (b)(4) 2014.Complaint details: the thread gets spliced/curled.Samples received: 9 unopened race-packs.The cause of the complaint could not be determined, and the eval still pending.Eval on-going as of the date of this report.

• Brand Name: PREMILENE 3/0 (2) 90CM 2XHRC26 CV
• Type of Device: POLYPROPYLENE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi, barcelona, es 0819 1
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona, es 0819 1
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4351401
• MDR Text Key: 5222670
• Report Number: 2916714-2014-00985
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K980703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: C2090812
• Device Catalogue Number: C2090812
• Device Lot Number: 113483V004
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other